Enhancement of Emmetropization in Hyperopic Infants

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Columbus,
Ohio43210

Purpose:

To determine if wearing a moderate spectacle under-correction (3.00D) and performing
activities designed to stimulate accurate accommodation during a 15-month period will
enhance emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.

Study summary:

The purpose of the project is to determine if emmetropization can be enhanced in very
farsighted babies. We will give them glasses with a partial correction, an amount that is
less than their full degree of farsightedness but enough to put them in the zone of
effective emmetropization. This 'boost' is meant to enable very farsighted babies to use
their eyes in a normal way and emmetropize as normal infants. This partial correction would
be given at 3 months of age for a period of up to 15 months. A program of visual engagement
is also provided in order to encourage the normal development and use of accommodation. As
changes in farsightedness occur, the power of the glasses will be reduced at follow up
appointments to keep the farsightedness within the zone of effective emmetropization. Once
an infant reaches a normal amount of farsightedness, the glasses would be discontinued.

Criteria:

Inclusion Criteria:
- 3 months of age (between 8 weeks and 20 weeks)at the baseline examination
- Either gender, any ethnicity
- Birthweight greater than 2500g
- Normal pregnancy and delivery (including Cesarean section delivery but excluding
serious complications or conditions such as eclampsia or rubella)
- Hyperopia of +5.00D or more but less than +7.00D spherical equivalent refractive
error in each eye by cycloplegic retinoscopy using cyclopentolate 1%
- Currently under the care of a pediatrician
Exclusion Criteria:
- Anisometropia greater than 1.00D (difference in spherical equivalent)
- Strabismus
- Previous history of difficulty with pupillary dilation
- History of cardiac, liver, asthma, or other respiratory disease
- History of ocular disease or active ocular inflammation

NCT ID:

NCT00574717

Primary Contact:

Principal InvestigatorDonald O. Mutti, OD, PhDThe Ohio State University College of Optometry

Backup Contact:

N/A

Location Contact:

Columbus, Ohio 43210United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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